臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 03, 2025
Last modified on	Mar. 03, 2025
Trial ID	jRCT1022240062

Scientific Title	Effects of exercise and nutritional intervention programs on immune cells and inflammatory cytokines in blood cancer survivors with sarcopenia: a randomized controlled trial
Public Title	The effects of exercise and nutritional intervention programs on immune cells and inflammatory cytokines in blood cancer survivors with sarcopenia

Contact for Scientific Queries	Name	Morishita Shinichiro
	Affiliation	Fukushima Medical University
	Address	10-6 Sakaemachi, Fukushima City 960-8516, Japan
	Telephone	+81-24-581-5538
	E-mail	morishit@fmu.ac.jp
Contact for Public Queries	Name	Morishita Shinichiro
	Affiliation	Fukushima Medical University
	Address	10-6 Sakaemachi, Fukushima City 960-8516, Japan
	Telephone	+81-24-581-5538
	E-mail	morishit@fmu.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		May. 01, 2025
Actual date of first enrollment
Target sample size		24
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	placebo control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1. Aged 18 or over at the time of obtaining consent 2. Survivors undergoing outpatient treatment after treatment for blood cancer 3. Patients who own a smartphone 4. Patients who have consented to participate in this study 5. Patients who have been diagnosed with sarcopenia using the AWGS 2019 sarcopenia diagnostic criteria (Chen LM, et al. 2020)
	Exclusion Criteria	1. Patients whose physical function assessment is affected by musculoskeletal disorders, cerebrovascular disorders, etc. 2. Patients whose physical function assessment is difficult due to complications 3. Patients who are unable to respond to questionnaires due to mental disorders or other complications 4. Patients whose attending physician deems participation in the study to be inappropriate
	Age Minimum	18age old over
	Age Maximum	100age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		hematologic cancer
Intervention(s)		The intervention group will receive a 3-month exercise intervention and nutritional intervention. The exercise intervention will involve guidance on the target number of steps to walk per day and resistance training. The nutritional intervention will involve guidance on taking nutritional supplements twice a day, after exercise and at any time of day.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		NK cell activity and two-color CD16/CD56 are measured as immune cell tests. TNF alpha and IL-6 are measured as inflammatory cytokine tests.
Secondary Outcome(s)

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Ethics Committee of Fukushima Medical University
Address	1 Hikarigaoka, Fukushima City, Fukushima, Fukushima
Telephone	+81-24-547-1825
E-Mail	fmucrb@fmu.ac.jp
Approval Status	Approval
Date of approval	Feb. 25, 2025

Plan to share IPD	Yes
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none